2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methylphenyl)-3-oxobutyramide]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 22 May 1979 to 28 May 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methylphenyl)-3-oxobutyramide]

EC Number:

228-771-0

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methylphenyl)-3-oxobutyramide]

Cas Number:

6358-37-8

Molecular formula:

C34H30Cl2N6O4

IUPAC Name:

2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(4-methylphenyl)-3-oxobutanamide]

Test animals

Species:

rabbit

Strain:

Californian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.38 kg (males) and 2.13 kg (females)
- Housing: individually
- Diet: commercial diet (Labsure, Christopher Hill Group), ad libitum
- Water: sterile filtered water, ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 +/-
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved, one flank intact, one flank abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

- Amount(s) applied: 0.5 ml test material

Duration of treatment / exposure:

24 h

Observation period:

7 days

Number of animals:

6 (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm2 gauze patch
- Type of wrap if used: aluminium foil and 6" wide "Coban" self adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: in accordance with OECD TG 404.
Scores were read 24 h, 72 h and 7 days after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately (after removal of the patches), 48 h and 6 days after end of exposure.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: after removal of the patches

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: intact skin sites

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: intact skin sites

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 6 days after end of exposure

Score:

0

Max. score:

4

Remarks on result:

other: intact skin sites

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: after removal of the patches

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: intact skin sites

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h, 6 days

Score:

0

Max. score:

4

Remarks on result:

other: intact skin sites

Irritant / corrosive response data:

Erythema:
Immediately after exposure:
6/6 intact skin sites and 5/6 abraded skin sites: erythema score 1
1/6 abraded skin site: erythema score 0

48 h after exposure:
4/6 intact skin sites and 2/6 abraded skin sites: erythema score 1
2/6 intact skin sites and 4/6 abraded skin sites: erythema score 0

6 days after end of exposure:
intact and abraded skin sites: no erythema (score 0)

Oedema:
Immediately after exposure:
6/6 intact skin sites and 2/6 abraded skin sites: oedema score 1
3/6 abraded skin sites: oedema score 2
1/6 abraded skin sites: oedema score 0

48 h and 6 days after exposure:
6/6 intact skin sites and 6/6 abraded skin sites: oedema score 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

The test material is not irritating to skin under these test conditions. This conclusion is legitimate even though the applied testing regime differs from today's standard methods: 24-h-exposure under occlusive conditions, 6 animals (required by OECD TG 404: 4 h, semiocclusive conditions, 3 animals). Slight skin reactions were observed, fully reversible by 6 days after end of exposure.
The test was performed with a test substance which contains relevant amounts of the submission substance. Therefore the test results are considered adequat to fulfill the endpoint requirements.

Executive summary:

 

The test material was tested for skin irritancy according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Both intact and abraded skin sites of six rabbits were exposed to 0.5 ml test substance for 24 hours under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Erythema and edema were observed in all animals immediately and 48 hours after exposure, fully reversible by 6 days after end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.